Is it safe to use Pepto Bismol 32-count recalled by Gold Star Distribution?

No. The recall cites CGMP deviations and unsanitary conditions at the distribution center. Consumers should stop using the product immediately and follow recall guidance.

Which products are affected by this recall?

Pepto Bismol 32-count tablets distributed nationwide by Gold Star Distribution. All lots within expiry are included.

What should I do if I already used some of the product?

Consult your healthcare provider if you have symptoms. Do not continue using the product. Follow the recall notification steps for refunds if applicable.

How can I tell if my lot is affected?

Check packaging for the recall notice. The recall states that all lots within expiry distributed by Gold Star Distribution are affected.

How do I get a refund or replacement?

Follow the distributor's notification method which requires two or more contact methods (email, fax, letter, press release, telephone, or in-person visit).

Who should I contact for more information?

Contact Gold Star Distribution Inc for guidance. The FDA recall page provides official details.

Will the product be safe after disposal?

Do not use the product. If you have the product, follow the recall guidance and contact the distributor for instructions on returns or disposal.

Is this recall part of a broader pattern for drug manufacturing?

The notice indicates CGMP deviations at the distribution center specific to this product. There is no indication from the recall that this is part of a broader industry pattern.

Where can I find the official recall notice and lot information?

The FDA enforcement page linked in the recall notice provides official details and lot information.

HIGHDecember 26, 2025

Gold Star Distribution Recalls Pepto Bismol 32-Count in 2025 Over CGMP Sanitation Violations

Q: What is the risk to consumers?

The recall identifies potential contamination due to insanitary conditions and rodent exposure at the distribution center, which could pose health risks if consumed.

Gold Star Distribution is recalling Pepto Bismol 32-count distributed nationwide after CGMP deviations and unsanitary conditions at its distribution center. The recall cites rodent exposure and unsanitary distribution practices. Consumers and healthcare providers should stop using this product immediately and contact Gold Star Distribution for guidance.

Quick Facts at a Glance

Recall Date: December 26, 2025
Hazard Level: HIGH
Brand: Gold Star Distribution
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact GOLD STAR DISTRIBUTION INC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

Pepto Bismol is an over-the-counter digestive health medication used to relieve upset stomach, indigestion, and diarrhea. This recall concerns packaging distributed nationwide by Gold Star Distribution.

Why This Is Dangerous

CGMP deviations led to insanitary conditions, including rodent exposure at the distribution center. This raises the risk of product contamination.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers could experience illness if contaminated. Immediate cessation of use is advised pending guidance and potential refunds.

Practical Guidance

How to identify if yours is affected

Check if your bottle is Pepto Bismol 32-count distributed by Gold Star Distribution.
Verify expiry date and compare to the lots described in the recall notice.
Inspect for packaging that references Gold Star Distribution as the distributor.

Where to find product info

FDA recall page linked in the notice and the product packaging.

What timeline to expect

Refunds or replacements typically take 4-6 weeks after the claim is submitted.

If the manufacturer is unresponsive

File a complaint with FDA or your state consumer protection office.
Keep records of your recall notices and any correspondence with the distributor.

How to prevent similar issues

Buy from reputable retailers and verify distributor information.
Watch for recall notices on the FDA recall database.
When purchasing medicines, check packaging and lot numbers for authenticity and safety certifications.

Documentation advice

Keep the product packaging, receipts, and recall notices. Save correspondence with the distributor for your records.

Product Details

Product: Pepto Bismol 32-count tablets (OTC digestive health medication)\nBrand: Pepto Bismol\nDistributor: Gold Star Distribution Inc\nRecall date: 2025-12-26\nStatus: Active\nHazard: CGMP deviations; unsanitary conditions; rodent exposure at distribution center\nSold nationwide in the United States\nExpiry: All lots within expiry distributed by Gold Star Distribution\nPrice: Unknown\nModel numbers: All lots within expiry distributed by Gold Star Distribution.

Key Facts

Active recall for Pepto Bismol 32-count distributed by Gold Star Distribution
CGMP deviations and insanitary conditions cited at the distribution center
Rodent exposure/activity identified as a contributing factor
All lots within expiry distributed by Gold Star Distribution are affected
Nationwide distribution in the United States
No injuries reported in the notice

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

6/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeOTC Digestive Health Medication

Product Details

Brand

Gold Star Distribution

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